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Ancient herb may help heart patients shed excess fluid

NCT ID NCT04691700

Symptom relief Sponsor: Takeshi Morimoto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding a traditional Japanese herbal medicine called Goreisan to standard heart failure treatment can help reduce fluid buildup (edema) in the body. About 1,179 adults with worsening heart failure and signs of fluid overload are being randomly assigned to receive either Goreisan plus standard care or standard care alone. The main goals are to see if Goreisan helps clear fluid and reduces the risk of death or hospitalization.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Goreisan (TJ-17), a traditional Japanese herbal medicine
What this could lead to
If it works, this could provide a way to reduce or stop diuretic use in heart failure patients while controlling fluid buildup.
What could go wrong
This is a Phase 4 trial, but results are not yet published. The herbal medicine may not improve outcomes or could interact with other drugs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

1,179 people

The number who actually took part.

Started

Jan 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Confirmed congestive heart failure (CHF) by Framingham criteria * CHF patients with cardiac edema and signs due to cardiac edema (signs of fluid overload: lower limb edema, pulmonary effusion, or pulmonary congestion on chest x-ray) * Elevated N-terminal pro brain-type natriuretic peptide (NT-proBNP) ≥300 pg/mL or brain natriuretic peptide (BNP) ≥100 pg/mL at enrollment * Patients ≥ 20 years of age, male or female * Provision of signed informed consent before any assessment is performed Exclusion Criteria: * Valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization * Implantation of a cardiac resynchronization therapy (CRT) within 12 weeks prior to enrollment or intent to implant a CRT device * Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization * End-stage renal failure (estimated glomerular filtration rate \[eGFR\] \<15 mL/min/1.73m2) at enrollment * Patients who are expected to have a life expectancy of 6 months or less * Acute coronary syndrome at screening * Women of child-bearing potential or women who have a positive pregnancy test at enrolment or randomization * Treatment with herbal medicine at enrollment * Confirmed poor tolerability of Goreisan (including cinnamon allergy) * Considered not appropriate for the participation of the study

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Conditions

The condition(s) this trial relates to.

congestive heart failure Edema heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clinical trial Edema Heart failure Kampo medicine Traditional japanese medicine

Contacts and locations

Locations

  • Kyoto University Graduate School of Medicine

    Kyoto, Kyoto, 606-8507, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.